Treatment of advanced prostate cancer could be set to change after the early publication of significant new trial results.
Doctors testing the pioneering hormone drug abiraterone found that it doubled the time taken for the disease to progress in men not yet on chemotherapy.
Abiraterone is already approved as a "last resort" treatment for prostate cancer that has stopped responding both to hormone therapies and the chemotherapy drug docetaxel. The new findings mean that in future it could be made available to a much larger group of patients.
Scientists halted the trial after an interim check in December last year found that men unknowingly taking abiraterone were doing much better than "control" patients not receiving the drug. The trial had been running for about a year. For ethical reasons, all the 1,088 participants are now being treated with abiraterone.
Prostate cancer not cured by surgery or radiotherapy is generally treated with therapies that stop tumour growth being fuelled by the male hormone testosterone.
Eventually, tumours become resistant to this treatment. Patients can go on to receive chemotherapy but this too proves ineffective in the end.
Abiraterone, developed at the Institute of Cancer Research in London, is a different kind of hormone therapy that works even in patients who are treatment resistant.
In May the National Institute for Health and Clinical Excellence (Nice), which vets new treatments for cost-effectiveness, recommended that abiraterone should be available on the NHS in England for prostate cancer that no longer responds either to standard hormone therapies or docetaxel.
But this excluded men who had not yet reached the stage of having to undergo toxic chemotherapy.
The new Phase III trial results, published online in the New England Journal of Medicine, showed that men taking abiraterone lasted an average 16.5 months before tumour growth could be detected by a CT or magnetic resonance imaging (MRI) scan. This was twice as long as the 8.3 month progression time for men in the placebo group.
Study leader Professor Johann de Bono, from the Institute of Cancer Research and Royal Marsden NHS Foundation Trust in London, said: "Abiraterone was initially approved for use in patients who had run out of standard treatment options, but this trial shows that if we can give patients the drug at an earlier stage we can slow their decline and block their cancer growth for longer.
"Abiraterone is not only keeping cancer in check and extending men's lives, but it is also set to deliver substantial benefits to men's quality of life, because its side-effects are so much milder than those of conventional chemotherapy."
The benefits were greater than those seen previously in men who moved on to abiraterone after chemotherapy treatment.
Men in the abiraterone group also reported less pain, and a less rapid decline in health-related quality of life.
There was a 25% reduced risk of death in patients receiving abiraterone. In their paper the researchers said this indicated "a strong trend toward improved survival". However, in terms of the way the study was conducted this result was not statistically significant.
New Advice On Prostate Cancer Screening
This year, the U.S. Preventive Services Task Force <a href="http://www.npr.org/blogs/health/2012/05/21/153234671/all-routine-psa-tests-for-prostate-cancer-should-end-task-force-says">recommended <em>against</em> routine prostate cancer screening</a> for men of all ages, noting its small benefits compared to the harms, published in the <em>Annals of Internal Medicine</em>. "We think the <a href="http://www.npr.org/blogs/health/2012/05/21/153234671/all-routine-psa-tests-for-prostate-cancer-should-end-task-force-says">benefit is very small</a>," Dr. Michael LeFevre, a member of the task force, told NPR's Shots blog. "Our range is between zero and one prostate cancer death avoided for every thousand men screened," which is minuscule compared to lives saved for screenings for conditions like colorectal cancer. A study published at the beginning of the year in the <em>Journal of the National Cancer Institute</em> seemed to back up the recommendations, noting that routine prostate cancer screening didn't seem to make a <a href="http://www.huffingtonpost.com/2012/01/06/prostate-cancer-screening-psa-test-deaths-men_n_1190558.html">difference in the risk of dying from prostate cancer</a>, Reuters reported. However, the American Society of Clinical Oncology issued advice after the USPSTF's recommendation, saying that whether a man gets routine prostate cancer screening should <a href="http://www.huffingtonpost.com/2012/07/17/prostate-cancer-screening-test-man-life-expectancy_n_1679499.html">depend on his life expectancy</a>. For example, men who aren't expected to live more than another 10 years should be discouraged from PSA testing, the Associated Press reported.
PSA Testing Could Mean Fewer Cases Of Deadly Prostate Cancer
To add more to the research on prostate cancer screening, a study in the journal <em>Cancer</em> showed that routine PSA testing is linked with 17,000 fewer cases of the deadliest form of prostate cancer. "By not <a href="http://www.webmd.com/prostate-cancer/news/20120730/study-psa-testing-cuts-worst-prostate-cancers">using PSA tests</a> in the vast majority of men, you have to accept you are going to increase very serious metastatic disease threefold," study researcher Dr. Edward Messing, M.D., the chief of urology at the University of Rochester Medical Center, told WebMD. Specifically, researchers calculated that without routine prostate cancer screenings through PSA testing, 25,000 men would have been diagnosed with <a href="http://www.webmd.com/prostate-cancer/news/20120730/study-psa-testing-cuts-worst-prostate-cancers">metastatic prostate cancer</a> (a deadly form of prostate cancer where it has spread beyond the prostate to elsewhere in the body) in 2008, compared with the 8,000 who were actually diagnosed with metastatic prostate cancer that year, WebMD reported.
Working The Night Shift Could Raise Your Risk
<a href="http://www.huffingtonpost.com/2012/10/25/night-shift-prostate-cancer-health_n_2003392.html">Working the night shift</a> is associated with a 2.77-times increased risk of prostate cancer, according to a study in the <em>American Journal of Epidemiology</em>. The study, conducted by Canadian researchers included 3,137 men with cancer and 512 men without cancer. The researchers also found that <a href="http://www.huffingtonpost.com/2012/10/25/night-shift-prostate-cancer-health_n_2003392.html">working the night shift</a> raised the risk of lung, colon, bladder, rectal and pancreatic cancers, as well as non-Hodgkin's lymphoma.
Surgery May Not Be The Best Option For Everyone With Prostate Cancer
Surgery may not always be the best option for men whose prostate cancer is detected with an elevated PSA (prostate-specific antigen) level, according to a study in the <em>New England Journal of Medicine</em>. For men with early prostate cancer who received a <a href="http://abcnews.go.com/Health/ProstateCancer/surgery-rarely-best-prostate-cancer-study-suggests/story?id=16805902#.UJrg9m_A_kh">radical prostatectomy</a> (prostate-removal surgery), 47 percent died after 12 years, while 49.9 percent of men who just underwent observation died after 12 years, ABC News reported. Plus 81 percent of men who underwent the radical prostatectomy <a href="http://www.webmd.com/prostate-cancer/news/20120718/prostate-cancer-surgery-may-not-always-up-survival">experienced erectile dysfunction</a> in the two years following, and urinary incontinence plagued 17 percent of the men, WebMD reported. However, ABC News did note that men whose <a href="http://abcnews.go.com/Health/ProstateCancer/surgery-rarely-best-prostate-cancer-study-suggests/story?id=16805902#.UJrg9m_A_kh">PSA scores were extremely high</a> -- above 10 -- benefited from receiving surgery, indicating that the study may suggest rather <em>which</em> men may benefit most from receiving a radical prostatectomy for their prostate cancer.
Aspirin Could Help Prostate Cancer Patients Live Longer
Prostate cancer patients who <a href="http://www.nytimes.com/2012/08/28/health/research/regular-aspirin-use-may-aid-prostate-cancer-recovery-study-finds.html">take aspirin</a> could cut their risk of dying from the disease, Harvard researchers reported this year. <em>The New York Times</em> reported on the study, published in the <em>Journal of Clinical Oncology</em>, which showed that taking aspirin cut in half the risk of <a href="http://www.nytimes.com/2012/08/28/health/research/regular-aspirin-use-may-aid-prostate-cancer-recovery-study-finds.html">dying of prostate cancer</a> over a decade -- 8 percent of aspirin-nontakers died, compared with 3 percent of aspirin-takers.
Circumcision Could Affect Risk
Circumcision -- or the removal of a man's foreskin before he has sex for the first time -- is linked with a <a href="http://www.huffingtonpost.com/2012/03/12/circumcision-prostrate-cancer_n_1339047.html">lower risk of developing prostate cancer</a>, Fred Hutchinson Cancer Research Center scientists found this year. The findings, published in the journal <em>Cancer</em>, shows that prostate cancer risk for <a href="http://www.huffingtonpost.com/2012/03/12/circumcision-prostrate-cancer_n_1339047.html">men who are circumcised</a> before the first time they have sex is 15 percent lower, compared with uncircumcised men. While Dr. Andrew Freedman, who is on the American Academy of Pediatrics' circumcision task force but was not involved in the study, found the findings thought-provoking, he told HuffPost in an earlier article that "this kind of epidemiological research -- how A affects B, and B affects C -- is very difficult to do and makes it very difficult to account for confounding variables."
Pan-Fried Meat Could Raise Risk
Including <a href="http://www.huffingtonpost.com/2012/08/20/pan-fried-meat-cancer-prostate-_n_1798970.html">pan-fried meat</a> in your weekly meal rotations is linked with a higher risk of prostate cancer, University of Southern California researchers found. Specifically, men who eat one-and-a-half servings of red meat that's been pan-fried each week have a 30 percent <a href="http://www.huffingtonpost.com/2012/08/20/pan-fried-meat-cancer-prostate-_n_1798970.html">increased risk of advanced prostate cancer</a>. And men who eat two-and-a-half servings of the food have a 40 percent increased risk. Hamburger meat in particular -- compared with a red meat like steak -- seemed linked with the increased risk, according to the <em>Carcinogenesis</em> study. And while not a red meat, pan-fried poultry also seemed linked with the <a href="http://www.huffingtonpost.com/2012/08/20/pan-fried-meat-cancer-prostate-_n_1798970.html">increased prostate cancer risk</a> (while <em>baked</em> poultry was associated with a lower prostate cancer risk).
Genetic 'Signatures' Could Predict Aggressive Disease
Genes could hold a clue to who will go on to <a href="http://www.huffingtonpost.com/2012/10/09/prostate-cancer-genetic-signatures-aggressive-tumors_n_1949724.html">develop aggressive prostate cancer</a>, researchers found this year. Reuters reported on the <em>Lancet Oncology</em> study, showing aggressive tumors might be able to be predicted by two <a href="http://www.huffingtonpost.com/2012/10/09/prostate-cancer-genetic-signatures-aggressive-tumors_n_1949724.html">genetic "signatures</a>": <blockquote>Researchers in Britain and the United States found that by reading the patterns of genes switched on and off in blood cells, they could accurately detect which advanced prostate cancer patients had the worst survival rates.</blockquote>
Blood Pressure Could Affect Risk Of Dying From Prostate Cancer
The risk of dying from prostate cancer is higher if you also<a href="http://www.huffingtonpost.co.uk/2012/10/23/blood-pressure-prostate-cancer-deaths_n_2004582.html?just_reloaded=1"> have high blood pressure</a>, European researchers found. Specifically, hypertension was linked with a 62 percent increased risk of dying for people with prostate cancer. "When we looked to see if the metabolic factors are related to an increased risk of getting or dying from prostate cancer we found a relationship with <a href="http://www.huffingtonpost.co.uk/2012/10/23/blood-pressure-prostate-cancer-deaths_n_2004582.html?just_reloaded=1">death from the disease and high blood pressure</a>," study researcher Christel Haggstrom, of Umea University, told HuffPost UK. "There was also a link to high BMI but blood pressure had the strongest association to increased risk. The results for BMI are in line with previous findings in large studies."
Green Tea Is Good
Research presented at the annual meeting of the American Association for Cancer Research this year showed that drinking green tea could <a href="http://www.eurekalert.org/pub_releases/2012-10/aafc-gtr101112.php">help ward off inflammation</a> in men with prostate cancer who are about to undergo prostate-removal surgery. "Our study showed that <a href="http://www.eurekalert.org/pub_releases/2012-10/aafc-gtr101112.php">drinking six cups of green tea</a> affected biomarkers in prostate tissue at the time of surgery," study researcher Susanne M. Henning, Ph.D., R.D., of the David Geffen School of Medicine at the University of California Los Angeles, said in a statement. "This research offers new insights into the mechanisms by which green tea consumption may reduce the risk for prostate cancer by opposing processes such as inflammation, which are associated with prostate cancer growth."
Living Longer With Prostate Cancer
In this medical video learn more about the treatments that are enabling men to live longer with prostate cancer.
Professor Alan Ashworth, chief executive of the Institute of Cancer Research, said: "Abiraterone has provided men with advanced prostate cancer with a treatment option where previously they had none, and we were always optimistic that it would have even more dramatic benefits when tested in men with earlier-stage disease.
"The new findings show that abiraterone when given before chemotherapy can double the length of time before a patient's cancer starts growing again, and are likely to herald even wider use of this important new drug."
Professor Martin Gore, medical director at The Royal Marsden, said: "Here at The Royal Marsden we have seen first hand the impact abiraterone has had on our patients with advanced prostate cancer. Patients are now living longer, and with fewer side-effects. To now see the positive effect this is having on patients with early-stage disease is an exciting development in prostate cancer research."
Each year almost 41,000 men develop prostate cancer in the UK and around 10,700 die from the disease.
Prof de Bono said: "The good news is that this at least doubles and maybe even trebles the number of patients who could be eligible for abiraterone. The data are absolutely spectacular."
He added: "A lot of patients never receive chemotherapy. They want to delay the transition to chemotherapy for as long as possible, and who can blame them.
"This is a drug which works better in patients who have never had chemotherapy. We are hopeful that Nice will soon approve the use of abiraterone before chemotherapy treatment, but this does raise the key issue of cost."
Abiraterone costs around £3,000 per patient per month. Nice initially refused to approve the drug on grounds of cost effectiveness.
Prof de Bono said abiraterone was just one of a clutch of new drugs coming through the pipeline that offered hope to men with advanced prostate cancer.
Trials for several of these medicines are now under way and could be yielding major results in the next 18 months.
One discovery under investigation is that resistence to abiraterone can be reversed by combining the drug with other agents.
Prof de Bono said the future was suddenly looking brighter for men with prostate cancer, who previously had few options once their disease reached an advanced stage.
"In the last couple of years we have completely rewritten the text book on treating prostate cancer," he said.